A Study to Evaluate NextScience® Xperience™ versus Normal Saline Irrigation Solution for Decreasing Bioburden After Primary Total Hip and Knee Arthroplasty

Overview

About this study

The purpose of this study is to determine the effectiveness of Next Science® Xperience™ Advanced Surgical Irrigation in reducing bacterial bioburden and acute periprosthetic joint infection rates after total hip and knee arthroplasty compared to standard of care irrigation.

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥ 18 years or older.
  • Scheduled to undergo primary total hip (via direct anterior approach, press-fit components) or total knee arthroplasty (via manual approach, cemented components).
  • Willing to comply with all study-related procedures and be available for the duration of the study.
  • Provide signed and dated informed consent.

Exclusion Criteria:

  • Patient < 18 years of age.
  • Unable to provide signed and dated informed consent.
  • Unwilling or unable to comply with all study-related procedures.
  • Known history of sensitivity or allergic reaction to any of the study products or its components, including any products used for standard of care (such as dressings or any coverings).
  • Has underlying condition or state that, in the 'investigator's opinion, would make them too critically ill to complete the day 90 postoperative follow ups.
  • Pregnant, planning to become pregnant, or nursing female subjects.
  • Subject with any mental impairment or condition that would make them unable to properly consent without use of LAR or additional subject protections.
  • Subject is a prisoner and/or part of a vulnerable subject population, which necessitates additional human research subject protections beyond the scope of this protocol.
  • Subject with an active infection or systemic antibiotic therapy within 2 weeks prior to surgery with the exception of preoperative antimicrobial prophylaxis.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Cameron Ledford, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Stephanie Giles

Giles.Stephanie@mayo.edu

More information

Publications

Publications are currently not available